Báo cáo y học: "A comparison of the MOS-HIV and SF-12v2 for measuring health-related quality of life of men and women living with HIV/AIDS" pptx

9 449 0
Báo cáo y học: "A comparison of the MOS-HIV and SF-12v2 for measuring health-related quality of life of men and women living with HIV/AIDS" pptx

Đang tải... (xem toàn văn)

Thông tin tài liệu

RESEARCH Open Access A comparison of the MOS-HIV and SF-12v2 for measuring health-related quality of life of men and women living with HIV/AIDS Allyson Ion 1* , Wenjie Cai 1 , Dawn Elston 2 , Eleanor Pullenayegum 3 , Fiona Smaill 2 , Marek Smieja 2,3,4 Abstract Background: The purpose of this study was to examine the relationship between the Medical Outcomes Study- HIV Health Survey (MOS-HIV) and the SF-12v2 to determine if the latter is adequate to assess the health-related quality of life (HRQoL) of men and women living with HIV/AIDS. 112 men and women living with HIV/AIDS who access care at a tertiary HIV clinic in Hamilton, Ontario were included in this cross-sectional analysis. Correlation coefficients of the MOS-HIV physical and mental health summary scores (PHS and MHS) and the SF-12v2 physical and mental component summary scales (PCS and MCS) were calculated along with common sub-domains of the measures including physical functioning (PF), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF) and mental health (MH) to explore the relationship between these two HRQoL measures. The sub- domains role physical (RP) and role emotional (RE) of the SF-12v2 were compared separately to the sub-domain role functioning (RF) of the MOS-HIV. Weighted kappa scores were calculated to determine agreement beyond chance between the MOS-HIV and SF-12v2 in assigning a HRQoL state (i.e. low, moderate, good, very good). Results: The MOS-HIV had mean PHS and MHS summary scores of 47.3 (SD = 11.5) and 49.2 (SD = 10.7) respectively. The mean SF-12v2 PCS and MCS scores were 47.7 (SD = 11.0) and 44.0 (SD = 10.4). The MOS-HIV and SF-12v2 physical and mental health summary scores were positively correlated (r = 0.84, p < 0.001 and r = 0.76, p < 0.001). All common sub-domains were significantly correlated at p values from < 0.001 to 0.034. Substantial agreement was observed in assigning a HRQoL state (Physical:  = 0.788, SE = 0.095; Mental:  = 0.707, SE = 0.095). Conclusions: This analysis validates the SF-12v2 for measuring HRQoL in adult men and women living with HIV/AIDS. Background Health-related quality of life (HRQoL) measures a per- son’s health status taking into account multiple dimen- sions including physical or func tional, psychological and social well-being and often relies on patient self-report. Patrick and Erickson broadly define HRQoL as the “value assigned to the duration of life as modified by the impairments, functional states, perceptions, and social opportunities that are influenced by disease, injury, treatment, or policy [1].” A paradigm s hift has occurred with HIV now being considered a chronic illness due to the advancement and availability of treatment and care. Introduction of highly active anti-retroviral therapy (HAART) has resulted in a significant decrease in HIV-related morbid- ity and mortality across the globe; however, people living with HIV/AIDS (PHAs) continue to face a variety of health-related challenges, w hich can affect many aspects of their quality of life. As a result, there has been increasing interest in understanding HRQoL in the context of HIV infection across a broad spe ctrum of HIV research including clinical tri als, observational stu- dies and community-based research. It is important, however, to ensure that the tools used to measure HRQoL are in tune with the current state of the HIV epidemic and reflect the experience of PHAs in their local and geographical context, while minimizing the burden placed on those who participate in research studies. * Correspondence: iona@mcmaster.ca 1 Health Research Methodology Program, Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada Full list of author information is available at the end of the article Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 © 2011 Ion et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the term s of the Creative Co mmons Attribution Licens e (h ttp://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provid ed the original work is properly cited. Over 17 generic and HIV-specific HRQoL measures are used in HIV research today and there is no consen- sus on which measures are best, especially considering that many of these measures were develope d in the pre- HAART era [2]. In a c omparative review by Clayson et al., the SF-36 was identified as the generic measure with the greatest evidence supporting its use in HIV/ AIDS research [2]. The Medical Outcomes Study HIV Health Survey (MOS-HIV) was identified as one of the preferred HIV-specific measures since it is brief and practical to administer, the input of PHAs was used in its development, t here is well-established evidence for its reliability, validity and responsiveness and it has been successfully used in clinical trials [2]. Shahriar et al. countered Clayson’s review stating that there was insuf- ficient evidence to recommend the use of the MOS-HIV over the SF-36 and that more head-to-head comparisons were needed [3]. The MOS-HIV is a 35-item questionnaire that includes eleven dimensions of HRQoL including general health perceptions (GHP), bodily pain (BP), physical func tioning (PF), role func tioning (RF), social functioni ng (S F), men- tal health ( MH), energy/vitality (EV), cognitive function- ing (CF), health distress (HD), overall quality of life (QL) and health transition (HT) allowing for the generation of physical (PHS) and mental (MHS) health summary scores. Development of the MOS-HIV began in 1987 and items selected from th e SF-20 were the foundation for its constructi on [3-5]. The MOS-HIV was developed to pro- vide a brief, comprehensive measure of functional status and well-being of PHAs enrolled in large-scale clinical trials and has been shown to be internally consistent and responsive to a number of outcomes including infections, adverse events, increased symptoms and AIDS-related events [2,4,5]. The MOS-HIV has also been used in stu- dies with a variety of patient groups including treatment- naïve, asymptomatic PHAs to those with more advanced HIV and opportunistic infections. MOS-HIV items are rescaled to a number between 0 and 100, with a higher score reflecting better health and HRQoL [4-6]. The 12-item short-form (SF-12v2) health survey, now in its second version, was developed out of a strategy to construct a shorter version of the SF-36 Health Survey reflecting the same sub-domains including general health perceptions (GHP), bodily pain (BP), physical functioning (PF), role physical (RP), role emotional (RE), social functioning (SF), mental health (MH) and energy/ vitality (EV) [4,7]. The SF-12v2 reproduces more than 90% of the variance of the physical and mental compo- nent summary scales of the SF-36 in the general US population, takes significantly less time to complete than the SF-36, reducing burden on research partici- pants; and demonstrated high two-week test-retest relia- bility correlations f or both the physical (r = 0.89) and mental (r = 0.76) health summary scores [6,8]. Han et al. demonstrated the SF-12v2 to be a reasonable and effective replacement for the SF-39, a similar measure to the MOS-HIV, in studies of people living with advanced HIVdiseasebycomparingfivedomainsoftheSF-12 (namely physical functioning, general health perceptions, bodily pain, mental health and energy/fatigue) to the SF-39 [9]. This analysis demonstrated that the burden of data requirements for both participants and investigators as well as redundan cy of questions asked could be reduced by using the SF-12v2 [8]. The purpose of this study was to give further rationale for using the SF-12v2 in HIV research by examining the relationship between the MOS-HIV and the SF-12v2 to deter mine if, when compared to the HIV-specific MOS- HIV, the SF-12v2 is an adequate measure to assess the health-related quality of adult men and women living with HIV/AIDS. Methods The study population consisted of 112 adult men and women living with HIV/AIDS who accessed care at the McMaster University Medical Centre Special Immunology Services outpatient clinic in Hamilton, Ontario and were enrolled in the Canadian HIV Vascular Study, a multi-cen- tre, prospective cohort study examining the relationship between HIV infection, anti-retroviral therapy and cardio- vascular disease. The Canadian HIV Vascular Study was approved by the Hamilton Health Sciences/McMaster University Faculty of Health Sciences Research Ethics Board; all part icipants gave their info rmed consent pr ior to their inclusion in this study and analysis of their data. MOS-HIV and SF-12v2 questionnaires completed on the same day during the Canadian HIV Vascular Study base- line interview were used. The MOS-HIV served as t he reference standard as it is the primary HIV-specific HRQoL measure used in clinica l and observational HIV research; there is no evidence that the SF-39, a similar HRQoL scale, has ever been used in HIV resea rch. The continuous PHS and MHS of the MOS-HIV and the PCS and MCS of the SF-12v2 were assessed for normality. Cor- relations between baseline physical and mental health summary scores of both measures were calculated using SPSS v17; Pearson correlation coefficients were calculated because of the lack of skew in the distributions of the summary scores. Pearson correlatio n coeffi cients were used to investigate the relationship between common sub- domains of the MOS-HIV and SF-12v2 including physical functioning (PF), bodily pain (BP), general health percep- tions (GH), energy/vitality (VT), social functioning (SF) and mental health (MH). The sub-domains role physical (RP) and role emotio nal (RE) of the SF-12v2 were com- pared separately to the domain role functioning (RF) of the MOS-HIV as these two domains capture the overall Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 2 of 9 “role functioning” measured in the MOS-HIV. Pearson correlation coefficients and the Multitrait-Multimethod Matrix method as outlined by Campbell and Fiske [10] were used to assess convergent and discriminant validity. Convergent validity indicates the degree to which sub- domains of the measures are related whereas discriminant validity indicates to what extent the sub-domains are not related theoretically; both convergent and discrimina nt validity were assessed statistically [11]. A cut-off of r ≥ 0.70 was chosen to determine the degree of convergent validity [12,13]; a cut-off of r < 0.85 was chosen to assess discriminant validity [11]. We also investigated agreement between the two mea- sures in assigning individuals to a HRQoL state, for example, low, moderate, good and very good HRQoL. Quartile values of the PHS and MHS from the MOS- HIV generated out of descriptive statistics of the cohort were used to establish levels of low (PHS: 0-39.09; MHS: 0-41.03), moderate (PHS: 39.10-48.47; MHS: 41.04-49.89), good (PHS: 48.48-57.34; MHS: 49.90- 58.50) and very good (PHS: 57.35-100; MHS: 58.51-100) HRQoL. SF-12v2 PCS and MCS quartile values were calculated for low (PCS: 0-41.02; MCS: 0-36.79), moder- ate (PCS: 41.03-51.35; MCS: 36.80-44.44), good (PCS: 51.36-56.27; MCS: 44.45-52.69) and very good (PCS: 56.28-100; MCS: 52.70-100) HRQoL and were com- pared to the MOS-HIV quartiles for each individual generating a 4 x 4 table. Weighted kappa ()scoresas per Fleiss and Cohen [14] were calculated using soft- ware by Cyr and Francis [15] in order to determine the chance-corrected agreement between the MOS-HIV and SF-12v2 in assigning individuals to levels of HRQoL. Weighted kappa values were interpreted as follows: less than 0 – poor agreement; 0 to 0.2 – slight agreement; 0.2 to 0.4 – fair agreement; 0.4-0.6 – moderate agree- ment; 0.6-0.8 – substantial agreement; 0.8-1.0 – almost perfect agreement [16]. A secondary analysis was conducted using the baseline clinical and HRQoL data from 96 of the men and women in the cohort from whom we had complete baseline data in order to determine the clinical validity of the SF-12v2 compared to the MOS-HIV. Pearson cor- relation coefficients were calculated in univariable analy- sis for all clinical variables of interest with each HRQoL summary score from both measures. Four linear regres- sion models were created in SPSSv17 utilizing the physi- cal health and mental health summary scores of both the SF-12v2 and MOS-HIV as outcome measures. T he overall fit of each model was assessed and standardized beta coefficients for each clinical variable of interest were reviewed for statistical significance and contribu- tion to the model. The following clinical variables were included in each regression model: age, gender, years living with HIV, smoking (current and former), current marijuana use, drug use (including cocaine and heroin), currentreceiptofaNNRTI-basedorPI-basedHAART regimen, nadir CD4 ce ll count and av erage number of hours slept each night. These variables were chosen because they have shown to affect physical or mental HRQoL in the literature [17-28]. Results Table 1 present s baseline charac teristics of the 112 men and women living with HIV/AIDS who were included in the analysis. The cohort was predominantly male with a mean age of 49.1 years (SD = 8.2) and Caucas ian ethni- city. The HIV transmission risk factor cited most fre- quently was sex with other men (61.6%) followed by heterosexual/bisexual sex (29.5%) and injection drug use (6.3%). The cohort had a mean CD 4 T-lymphoc yte count of 507 cells/ml of blood at their baseline study visit (SD = 280.3) and ha d lived with HIV, on average, for 12.0 years (SD = 7.6). Table 2 presents the descrip- tive statistics for the physical and mental health sum- mary scores as well as all domains of the MOS-HIV and SF-12v2. The mean MOS-HIV physical health summary score was 47.3 (SD = 11.5) ranging from 22.4 to 63.2 whereas the mean MOS-HIV m ental health summary score was 49.2 (SD = 10.7) ranging from 20.5 to 66.7. The mean physical and mental component summary scales of the SF-12v2 were similar at 47.7 (SD = 11.0) ranging from 16.2 t o 63.4 and 44.0 (SD = 10.4) ranging from 16.7 to 62.4, respectively. Table 1 Baseline characteristics of participants N = 112 Mean (SD); Min-Max Age (years) 49.1 (8.2); 31-75 Number of years living with HIV 12.0 (7.6); 1-52 Baseline CD4 (at study visit) 507.4 (280.3); 50-1170 N (%) Gender Male 97 (86.6) Female 14 (12.5) Transgendered 1 (0.9) Currently receiving HAART 87 (77.7) Ethnicity Caucasian 100 (89.3) Black 7 (6.3) Other 3 (2.7) First Nation 2 (1.8) HIV Transmission Risk Factor MSM 69 (61.6) Heterosexual/Bisexual 33 (29.5) IDU 7 (6.3) Hemophilia 5 (4.5) Blood Products 3 (2.7) Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 3 of 9 Table 3 presents correlation coefficients computed comparing the physical and mental health summary scores of the MOS-HIV and SF-12v2 as well as scores of all sub-domains in each measure. The MOS-HIV and SF- 12v2 were positively correlated with regard to b oth the physical and mental health summary scores respectively (r = 0.84, p < 0.001 and r = 0.76, p < 0.001). A compari- son of the MOS-HIV and SF-12v2 common domains including PF, BP, GH, VT, SF and MH yielded positive correlations f or all categories (PF: r = 0.90; BP: r = 0.82; GH:r=0.80;VT:r=0.72;SF:r=0.68;MH:r=0.58;all significant at p < 0.001). The domains role physical and role emotional of the SF- 12v2 were compared separately to the domain role functioning of the MOS-HIV yiel ding slightly lower, yet positive co rrelati ons (RP: r = 0.69; RE: r = 0.49; p < 0.001). Tables 4 and 5 present the inter- domain correlations of the SF-12v2 and MOS-HIV, respectively. Five of the inter-scale correlations of the SF- 12v2 were low (r range = 0.24-0.39), however, the remaining correlations were moderately to highly asso- ciated (r range = 0.40-0.86, all statistically significant at p values from < 0.001 to 0.012). Inter-scale correlations of the MOS-HIV were similar with moderate to high inter- scale correlations ranging from 0.40 to 0.70, all statisti- cally signifi cant at p < 0.001. The two exceptions were the associations between the PF and MH (r = 0.36) and between GH and CF (r = 0.39). Overall, by comparing the Pearson correlations between the measures as well as the inter-domain correlations within the SF-12v2 and MOS-HIV to the cut-off values of r≥0.70 and r < 0.85 chosen, it was demonstrated that both instruments have good convergent and discriminant validity, respectfully. The MOS-HIV and SF-12v2 demonstrated substantial agreement for assigning individuals to specific states of HRQoL based on their MOS-HIV physical and mental health summary scores with weighted  scores of 0.788 (SE = 0.095) and 0.707 (SE = 0.095) for agreement of physical and mental health, respectively. Lastly, the univariable and multivariable analyses inves- tigating clinical correlates of HRQoL between the SF- 12v2 and MOS-HIV demonstrated moderate agreement (Table 6). There was similar directionality and magnitude of association between the two measures for both the physical and mental health summary scores. In univari- able analysis, a history of drug use was associated with a lower physical health summary score for both the MOS- HIV [r = - 0.216 (95% CI - 0.399, - 0.017)] an d SF-12v2, however the correlation was not significant for the SF- 12v2 [r = - 0.157 (95% CI - 0.346, 0.044)]. The MOS-HIV and SF-12v2 mental health summary scores demo n- strated similar trends with regard to male gender [MOS- HIV: r = 0.222 (95% CI 0.023, 0.404); SF-12v2: r = 0.164 (95% CI - 0.037, 0.352)] and hours slept each night [MOS-HIV: r = 0.194 (95% CI - 0.006, 0.379); SF-12v2: r = 0.207 (95% CI 0.007, 0.391)]. In multivariable analysis, the trend for the MHS was maintained for male gender (MOS-HIV: b = 0.260, p = 0.013; SF-12v2: b =0.199,p= 0.052) and hours slept each night (MOS-HIV: b = 0.283, p = 0.011; SF-12v2: b = 0.270, p = 0.014). The one discre- pancy between the two measures was with regard to Table 2 Mean, Standard Deviation, Median and Min-Max Values for Components/Domains of MOS-HIV and SF-12v2 (n = 112) MOS-HIV SF-12v2 Component or Domain Mean (SD) Median Min-Max Component or Domain Mean (SD) Median Min-Max PHS 47.3 (11.5) 48.5 22.4-63.2 PCS 47.7 (11.0) 51.3 16.2-63.4 MHS 49.2 (10.7) 49.9 20.5-66.7 MCS 44.0 (10.4) 44.4 16.7-62.4 GHP 48.9 (10.6) 48.3 28.9-67.6 GHP 45.4 (11.4) 44.7 18.9-62.0 BP 50.8 (9.1) 50.6 27.6-62.2 BP 46.0 (11.9) 47.3 16.7-57.4 PF 47.8 (11.2) 51.2 20.2-58.1 PF 47.3 (11.4) 52.2 22.1-56.5 RF 48.0 (10.8) 56.6 32.0-56.6 RP 46.4 (10.6) 48.0 20.3-57.2 RE 44.6 (12.2) 44.9 11.3-56.1 SF 46.5 (11.6) 47.8 10.2-57.2 SF 43.7 (11.2) 46.5 16.2-56.6 MH 50.7 (11.7) 53.6 17.5-66.3 MH 43.3 (10.0) 46.3 15.8-64.5 EV 47.4 (11.6) 48.9 24.3-68.6 EV 49.3 (9.9) 47.7 27.6-67.9 CF 46.3 (10.9) 48.3 14.1-58.1 HD 51.8 (10.5) 53.7 20.4-62.0 QL 49.2 (9.8) 53.0 27.7-65.6 Abbreviations: PHS - physical health summary score; MHS - mental health summary score; PCS - physical component summary scale; MCS - mental component summary scale; GHP - general health perceptions; BP - bodily pain; PF - physical functioning; RF - role functioning; RP - role physical; RE - role emotional; SF - social functioning; MH - mental health; EV - energy/vitality; CF - cognitive functioning; HD - health distress; QL - quality of life. Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 4 of 9 smoking history and the mental health summary score. In univariable analysis, the mental heal th summary score of both measures was not significantly correlated with being a current smoker [MOS-HIV: r = - 0.011 (95% CI - 0.211, 0.189); SF-12v 2: r = 0.044 (95% CI - 0.157, 0.242) ] or former smoker [MOS-HIV: r = - 0.014 (95% CI -0.213, 0.187); SF-12v2: r = 0.048 (95% CI -0.153, 0.246)]. In multivariable analysis, current smoker and former smo- ker were significant predictors of the MOS-HIV MHS (b = 4.226, p = 0.044; b = -4.25, p = 0.043, respectively), but not of the SF-12v2 MCS (b =1.867,p=0.363;b = -1.865, p = 0.364, respectively), even though directionality of the associations were similar. It should be noted that only the regression model involving the SF-12v2 MCS as the dependent variable was statistically significant (F = 1.955, p = 0.044). The other regression models we re not significant: SF-12v2 PCS – F = 0.924, p = 0.522; MOS- HIV MHS: F = 1.735, p = 0.80; MOS-HIV PHS: F = 1.352, p = 212. Discussion This preliminary analysis suggests that the SF-12v2 is an appropriate measure of health-related quality of life of men and women living with HIV/AIDS compared to the MOS-HIV demonstrating high correlation and good convergent and discrim inan t validity when compared to the physical and mental health summary scores o f the MOS- HIV and common sub-domains. Furthe rmore, the Table 3 Correlation between SF-12v2 and MOS-HIV (n = 112) MOS-HIV PF PN GH VT SF MH RF CF QL HD PHS MHS SF12v2 PF 0.9 0.68 0.63 0.61 0.41 0.31 0.62 0.41 0.47 0.56 0.84 0.52 BP 0.62 0.82 0.5 0.52 0.43 0.37 0.46 0.36 0.36 0.55 0.7 0.49 GH 0.56 0.52 0.8 0.64 0.43 0.41 0.47 0.2 0.58 0.45 0.66 0.56 VT 0.54 0.48 0.6 0.72 0.39 0.36 0.43 0.36 0.54 0.37 0.62 0.55 SF 0.4 0.46 0.44 0.5 0.68 0.64 0.37 0.4 0.53 0.5 0.52 0.65 MH 0.45 0.49 0.57 0.76 0.53 0.58 0.43 0.52 0.57 0.51 0.59 0.71 RP 0.78 0.67 0.7 0.7 0.53 0.39 0.69 0.38 0.55 0.5 0.85 0.58 RE 0.44 0.49 0.47 0.66 0.55 0.68 0.49 0.63 0.46 0.64 0.56 0.75 PCS 0.85 0.74 0.69 0.57 0.4 0.24* 0.6 0.25 0.46 0.49 0.84 0.44 MCS 0.27* 0.36 0.45 0.69 0.58 0.71 0.36 0.56 0.54 0.52 0.44 0.76 SF12: PF = physical functioning; BP = bodily pain; GH = general health perceptions; VT = vitality; SF = social functioning; MH = mental health; RP = role physical; RE = role emotional; PCS = physical component summary scale; MCS = mental component summary scale. MOS-HIV: PF = physical functioning; PN = pain; GH = general health perceptions; VT = energy/fatigue; SF = social functioning; MH = mental health; RF = role functioning; CF = cognitive function; QL = quality of life; HD = health distress; HT = health transition; PHS = physical health summary; MHS = mental health summary. Note: All correlations were statistically significant at p < 0.001 except for *, which were significant at p < 0.05. Table 4 Inter-domain correlations within SF-12v2 (n = 112) PF BP GH VT SF MH RP RE PCS MCS PF 0.66* 0.50* 0.54* 0.37* 0.45* 0.77* 0.39* 0.89* 0.21+ BP 0.47* 0.42* 0.41* 0.44* 0.62* 0.39* 0.80* 0.26+ GH 0.59* 0.40* 0.55* 0.54* 0.33* 0.66* 0.41* VT 0.24* 0.86* 0.59* 0.45* 0.49* 0.65* SF 0.40* 0.43* 0.55* 0.35* 0.61* MH 0.51* 0.59* 0.36* 0.84* RP 0.54* 0.82* 0.37* RE 0.25+ 0.83* PCS 0.08 MCS SF12: PF = physical functioning; BP = bodily pain; GH = general health perceptions; VT = vitality; SF = social functioning; MH = mental health; RP = role physical; RE = role emotional; PCS = physical component summary scale; MCS = mental component summary scale. *: Statistically significant (p < 0.001). +: Statistically significant (p < 0.05). Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 5 of 9 SF-12v2 had substantial agreement with the MOS-HIV in assigning individuals to a specific HRQoL status and determining clinically relevant correlates of HRQoL. It is impo rtant to point out that this an alysis does not account for the HRQoL domains of cognitive function- ing, health distress and health transition, which are cap- tured in the MOS-HIV but are not represented in the SF-12v2. These doma ins are u sed to derive the mental health summary score of the MOS-HIV, which may help to explain the weaker correlation between the mea- sures in the MHS as well as the differences in determin- ing clinically relevant correlates of HRQoL. If the SF- 12v2 is used as a HRQoL measure in any HIV research study, it would have to be with the caveat that these three HRQoL domains were not important outcomes or were not relevant to the population under study. It should be noted that the mean physical and mental health summary scores were lower than the mean score of 50 for the reference popu lation. This supports the lit- erature that despite the advancement of HAART and decline in HIV-related morbidity and mortality, people living with HIV continue to experience health-related challenges and generally have lower physical and mental HRQoL scores w hen compared to the general popula- tion. A cross-sectional questionnaire-based study con- ducted by Miners et al. found that men and women living with HIV in the United Kingdom scored lower on all five domains on the EQ-5D quality of life measure including mobility, self-care, usual activities, pain/dis- comfort and anxiety/depression irrespective of similari- ties in age and gender [22]. Univariable and sub sequent multiv ariable regression analysis demonstrated that peo- ple living with HIV had significantly lower utility and visual analogue scale scores on the EQ-5D compared with the general population; HIV infection indepen- dently decreased the utility and visual analogue scale scores of the EQ-5D by 20% [22]. In addition, the mean mental health summary scores were relatively higher for people completing the MOS -HIV compared to the SF- 12v2. This may reflect the additional domains captured in the MOS-HIV (i.e. health distress, health transition, etc.) that are combined to determine the mental health summary score or may have arisen due to chance. The SF-12v2 is currently being used in HIV research in Canada to better understand the HRQoL of indivi- duals living with HIV/AIDS including assessing changes over time, but had n ot been formally compared to the MOS-HIV. The Canadian HIV Vascular Study investiga- tors chose the SF-12v2 over the MOS-HIV in order to reduce questionnaire burden on participants, and the SF-12v2 is also being used in the Ontario HIV Treat- ment Network Cohort Study to understand yearly changes in HRQoL. The SF-12v2 is a contemporary HRQoL measurement tool with accessible language and efficiency in its administration. Ease in reading and comprehending the SF-12v2 would also result in fewer errors by the participant. Although this is not necessarily synonymous with the level of understanding of the intended meaning of the items, anecdotally, the authors have experienced mini- mal issues in interpreting the SF-12v2, but have often had questions from participants co mpleting the MOS- HIV, including redefinition of colloquial language such as “pep,”“blue” and “down in the dumps.” The MOS- HIV typically takes much longer to complete than the SF-12v2. Locally, participants involved in research at the McMaster University Medical Centre usually need 5 to 10 minutes to c omplete the MOS-HIV, whereas Table 5 Inter-domain correlations within MOS-HIV (n = 112) PF PN GH VT SF MH RF CF QL HD PHS MHS PF 0.67 0.69 0.67 0.50 0.36 0.64 0.43 0.56 0.58 0.90 0.58 PN 0.61 0.66 0.46 0.47 0.54 0.49 0.47 0.63 0.81 0.61 GH 0.68 0.51 0.47 0.64 0.39 0.62 0.60 0.82 0.68 VT 0.62 0.62 0.57 0.50 0.62 0.61 0.80 0.79 SF 0.70 0.44 0.48 0.58 0.56 0.66 0.76 MH 0.40 0.60 0.50 0.68 0.48 0.89 RF 0.47 0.46 0.55 0.81 0.58 CF 0.41 0.70 0.52 0.77 QL 0.45 0.64 0.71 HD 0.65 0.85 PHS 0.72 MHS MOS-HIV: PF = physical functioning; PN = pain; GH = general health perceptions; VT = energy/fatigue; SF = social functioning; MH = mental health; RF = role functioning; CF = cognitive function; QL = quality of life; HD = health distress; HT = health transition; PHS = physical health summary; MHS = mental health summary. Note: All p values are < 0.001. Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 6 of 9 individuals can usually complete the SF-12v2 in less than 2 minutes and express ease i n completing the SF- 12v2 more so than the MOS-HIV. Miscomprehension of terms used in HRQoL measures by participants can result in inaccurate measurement of this important con- struct. It is important to use a HRQoL measure that is culturally relevant, accessible, quick to administer and reflects the current experiences of PHAs. It should be acknowledged that it was not possible to ask participants directly regarding the ‘burden’ or time required to complete both the MOS-HIV and SF-12v2. This would have offered an interesting perspective to this analysis and the subsequent decision of which mea- sure to use in HIV research studies . Another considera- tion when measuring HRQoL is to what extent the items and dimensions captured in the scale resonate with participants and accurately depict the current rea- lity of PHAs. It was not possible to elicit feedback from Table 6 Correlation coefficients (95% CIs) and multivariable regression (standardized beta coefficients) exploring correlates of HRQoL Clinical variable of interest MOS-HIV SF-12v2 MOS-HIV SF-12v2 Physical health summary score (PHS) Physical component summary scale(PCS) Mental health summary score (MHS) Mental component summary scale(MCS) r (95% CI) r (95% CI) r (95% CI) r (95% CI) b (p value) b (p value) b (p value) b (p value) Age r = -0.011 r = -0.067 r = 0.128 r = 0.228 (-0.211, 0.189) (-0.767, 0.543) (-0.074, 0.320) (0.029, 0.409) b = -0.063 (p = 0.579) b = -0.116 (p = 0.321) b = 0.153 (p = 0.169) b = 0.215 (p = 0.052) Male Gender r = 0.155 r = 0.115 r = 0.222 r = 0.164 (-0.046, 0.344) (-0.087, 0.308) (0.023, 0.404) (-0.037, 0.352) b = 0.174 (p = 0.099) b = 0.102 (p = 0.345) b = 0.260 (p = 0.013) b = 0.199 (p = 0.052) Years living w HIV r = -0.117 r = -0.166 r = -0.059 r = 0.197 (-0.310, 0.085) (-0.354, 0.035) (-0.143, 0.256) (-0.003, 0.382) b = -0.163 (p = 0.161) b = -0.213 (p = 0.076) b = -0.016 (p = 0.886) b = 0.130 (p = 0.246) Current smoker r = -0.113 r = -0.069 r = -0.011 r = 0.044 (-0.306, 0.089) (-0.265, 0.133) (-0.211, 0.189) (-0.157, 0.242) b = -0.973 (p = 0.646) b = -1.279 (p = 0.556) b = 4.226 (p = 0.044) b = 1.867 (p = 0.363) Former smoker r = -0.105 r = -0.064 r = -0.014 r = 0.048 (-0.299, 0.097) (-0.261, 0.138) (-0.213, 0.187) (-0.153, 0.246) b = 0.869 (p = 0.681) b = 1.240 (p = 0.568) b = -4.254 (p = 0.043) b = -1.865 (p = 0.364) Currently uses marijuana r = -0.099 r = -0.065 r = -0.032 r = -0.045 (-0.293, 0.103) (-0.262, 0.137) (-0.231, 0.169) (-0.243, 0.156) b = -0.186 (p = 0.098) b = -0.097 (p = 0.397) b = -0.128 (p = 0.244) b = -0.143 (p = 0.187) Has used drugs (including cocaine and heroin) r = -0.216 r = -0.157 r = -0.119 r = -0.103 (-0.399, -0.017) (-0.346, 0.044) (-0.312, 0.083) (-0.297, 0.099) b = -0.199 (p = 0.081) b = -0.129 (p = 0.266) b = -0.179 (p = 0.109) b = -0.094 (p = 0.392) Currently receiving PI-based regimen r = 0.016 r = -0.027 r = 0.084 r = 0.137 (-0.185, 0.215) (-0.226, 0.174) (-0.118, 0.279) (-0.065, -0.128) b = 0.067 (p = 0.582) b = 0.025 (p = 0.843) b = 0.117 (p = 0.326) b = 0.157 (p = 0.185) Currently receiving NNRTI- based regimen r = 0.177 r = 0.141 r = 0.125 r = 0.181 (-0.024, 0.364) (-0.061, 0.332) (-0.077, 0.317) (-0.020, 0.368) b = 0.087 (p = 0.479) b = 0.116 (p = 0.357) b = 0.006 (p = 0.961) b = 0.050 (p = 0.672) Hours slept each night r = 0.078 r = -0.008 r = 0.194 r = 0.207 (-0.124, 0.274) (-0.208, 0.192) (-0.006, 0.379) (0.007, 0.391) b = 0.141 (p = 0.209) b = -0.018 (p = 0.877) b = 0.283 (p = 0.011) b = 0.270 (p = 0.014) Nadir CD4 cell count r = -0.057 r = -0.067 r = -0.093 r = -0.045 (-0.254, 0.154) (-0.263, 0.135) (-0.288, 0.109) (-0.767, -0.543) b = -0.018 (p = 0.883) b = -0.080 (p = 0.515) b = -0.018 (p = 0.880) b = 0.112 (p = 0.336) Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 7 of 9 PHAs via focus groups or in-depth interviews prior to inclusion of the MOS-HIV and SF-12v2 in this analysis; this would have offered another interesting perspective to this comparison. This analysis may not be generalizable to all PHAs. The cohort was comprised predominantly of men with an average age of 48.6 years (ranging from 31 to 75 years) whose major HIV transmission risk factor was intercourse with other men; the study sample is reflec- tive of the early HIV epidemic and may not be compar- able to today’s population of people living with HIV/ AIDS. Eighty-nine per cent were of Caucasian ethnicity and only 12.6% of the cohort were women, therefore, caution should be taken when attempting to apply these results to people from different ethnocultural commu- nities and gender identities. These findings must also be considered with caution due to the relatively small sam- ple size. Conclusions This preliminary analysis suggests that the SF-12v2 is an efficient and practical H RQoL questionnaire taking, on average, less than two minutes to complete. This HRQoL measure may enable timely collection of quality of life data in b roader areas of research than in the past while reducing the redundancy and questionnaire bur- den placed on participants. Confirmatory studies in lar- ger and more representative populations are needed. Acknowledgements The authors wish to acknowledge funding received from the Canadian Institutes of Health Research http://www.cihr-irsc.gc.ca for the Canadian HIV Vascular Study, which was the source of data for this manuscript. The funding agency had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Author details 1 Health Research Methodology Program, Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. 2 Department of Pathology and Molecular Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. 3 Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. 4 St. Joseph’s Healthcare, Hamilton, Ontario, Canada. Authors’ contributions AI and MS conceived the design of the study, performed and interpreted the statistical analysis and helped to draft the manuscript. FS participated in the design of the study and helped to draft the manuscript. DE and WC participated in the coordination of the study, assisted with the statistical analysis and helped to draft the manuscript. EP assisted with development and interpretation of the statistical analysis and helped to draft the manuscript. All authors read and approved the final manuscript. Competing interests The authors declare that they have no competing interests. Received: 24 February 2010 Accepted: 27 January 2011 Published: 27 January 2011 References 1. Patrick DL, Erickson P: Health status and health policy: quality of life in health care evaluation and resource allocation. New York: Oxford University Press; 1993. 2. Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ: A Comparative Review of Health-Related Quality-of-Life Measures for Use in HIV/AIDS Clinical Trials. Pharmacoeconomics 2006, 24:751-765. 3. Shahriar J, Delate T, Hays RD, Coons SJ: Commentary on using the SF-36 or MOS-HIV in studies of persons with HIV disease. Health and Quality of Life Outcomes 2003, 1:25. 4. Wu AW, Hays RD, Kelly S, Malitz KF, Bozzette SA: Applications of the Medical Outcomes Study health-related quality of life measures in HIV/ AIDS. Qual Life Res 1997, 6:531-554. 5. Wu AW, Revicki DA, Jacobson D, Malitz FE: Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS- HIV). Qual Life Res 1997, 6:481-493. 6. Revicki DA, Sorensen A, Wu AW: Reliability and Validity of Physical and Mental Health Summary Scores from the Medical Outcomes Study HIV Health Survey. Medical Care 1998, 36:126-137. 7. Ware JE, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey. Medical Care 1996, 34:220-233. 8. Mannheimer SB, Matts J, Telzak E, Chesney M, Child C, Wu AW, Friedland G for the Terry Beirn Community Programs for Clinical Research on AIDS: Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care 2005, 17:10-22. 9. Han C, Pulling CC, Telke SE, Hullsiek KH for the Terry Beirn Community Programs for Clinical Research on AIDS: Assessing the utility of five domains in SF-12 Health Status Questionnaire in an AIDS clinical trial. AIDS 2002, 16:431-439. 10. Campbell DT, Fiske DW: Convergent and Discriminant Validation by the Multitrait-Multimethod Matrix. Psych Bulletin 1959, 56:81-105. 11. John OP, Benet-Martinez V: Measurement: Reliability, construct validation, and scale construction. In Handbook of research methods in social psychology. Edited by: Reis HT & Judd CM. New York: Cambridge University Press; 2000:339-369[http://en.wikipedia.org/wiki/Discriminant_validity]. 12. Kinnear TC, Taylor JR: Marketing Research: An Applied Approach. Singapore: McGraw-Hill Book Company, 3rd 1987. 13. Litwin MS: How to Measure Survey Reliability and Validity. London: Sage; 1995. 14. Fleiss JL, Cohen J: The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educational Psychological Measurement 1973, 33:613-619. 15. Cyr L, Francis K: Measurement of Clinical Agreement for Categorical Data: Kappa Coefficients (PC software. 1992. 16. Meade MO, Cook RJ, Guyatt GH, Groll R, Kachura JR, Bedard M, Cook DJ, Slutsky AS, Stewart TE: Interobserver Variation in Interpreting Chest Radiographs for the Diagnosis of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med 2000, 161:85-90. 17. Panel on Antiretroviral Guidelines for Adults and Adolescents: Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescent. Department of Health and Human Services; 2008, 1-139[http:// www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf], February 28, 2009. 18. Burgoyne RW, Tan DHS: Prolongation and quality of life for HIV-infected adults treated with highly active antiretroviral therapy (HAART): a balancing act. J Antimicrobial Chemo 2008, 61:469-473. 19. Gill C, Griffith JL, Jacobson D, Skinner S, Gorbach SL, Wilson IB: Relationship of HIV Viral Loads, CD4 Counts, and HAART Use to Health-Related Quality of Life. JAIDS 2002, 30:485-492. 20. Korthuis PT, Zephyrin LC, Fleishman JA, Saha S, Josephs JS, McGrath MM, Hellinger J, Gebo KA: Health-related quality of life in HIV-infected patients: the role of substance use. AIDS Patient Care STDs 2008, 22:859-867. 21. Weinfurt KP, Willke RJ, Glick HA, Freimuth WW, Schulman KA: Relationship between CD4 count, viral burden, and quality of life over time in HIV-1- infected patients. Medical Care 2000, 38:404-410. 22. Miners AH, Sabin CA, Mocroft A, Youle M, Fisher M, Johnson M: Health- Related Quality of Life in Individuals Infected with HIV in the Era of HAART. HIV Clin Trials 2001, 2:484-492. Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 8 of 9 23. Bucciardini R, Fragola V, Massella M, Polizzi C, Mirra M, Goodall R, Carey D, Hudson F, Zajdenverg R, Floridia M: Health-related quality of life outcomes in HIV-infected patients starting different combinations regimens in a randomized multinational trial: the INITIO-QoL substudy. In AIDS Research and Human Retroviruses. Volume 23. Initio Trial International Coordinating Committee; 2007:1215-1222. 24. Casado A, Badia X, Consiglio E, Ferrer E, Gonzalez A, Pedrol E, Gatell JM, Azuaje C, Llibre JM, Aranda M, Barrufet P, Martinez-Lacasa J, Podzamczer D and the COMBINE Study Team: Health-related quality of life in HIV- infected naive patients treated with nelfinavir or nevirapine associated with ZDV/3TC (the Combine-QoL Substudy). HIV Clin Trials 2004, 5:132-139. 25. Casado A, Consiglio E, Podzamczer D, Badia X: Highly active antiretroviral treatment (HAART) and health-related quality of life in naive and pretreated HIV-infected patients. HIV Clin Trials 2001, 2:477-483. 26. Revicki DA, Moyle G, Stellbrink HJ, Barker C, PISCES Study Group: Quality of life outcomes of combination zalcitabine-zidovudine, saquinavir- zidovudine, and saquinavir-zalcitabine-zidovudine therapy for HIV- infected adults with CD4 cell counts between 50 and 350 per cubic millimeter. AIDS 1999, 13:851-858. 27. Stangl AL, Wamai N, Mermin J, Awor AC, Bunnell RE: Trends and predictors of quality of life among HIV-infected adults taking highly active antiretroviral therapy in rural Uganda. AIDS Care 2007, 19:626-636. 28. van Leth F, Conway B, Laplume H, Martin D, Fisher M, Jelaska A, Wit FW, Lange JMA for the 2NN Study Group: Quality of life in patients treated with first-line antiretroviral therapy containing and/or efavirenz. Antiviral Therapy 2004, 9:721-728. doi:10.1186/1742-6405-8-5 Cite this article as: Ion et al.: A comparison of the MOS-HIV and SF-12v2 for measuring health-related quality of life of men and women living with HIV/AIDS. AIDS Research and Therapy 2011 8:5. Submit your next manuscript to BioMed Central and take full advantage of: • Convenient online submission • Thorough peer review • No space constraints or color figure charges • Immediate publication on acceptance • Inclusion in PubMed, CAS, Scopus and Google Scholar • Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit Ion et al. AIDS Research and Therapy 2011, 8:5 http://www.aidsrestherapy.com/content/8/1/5 Page 9 of 9 . Ion et al.: A comparison of the MOS-HIV and SF-12v2 for measuring health-related quality of life of men and women living with HIV/AIDS. AIDS Research and Therapy 2011 8:5. Submit your next manuscript. Access A comparison of the MOS-HIV and SF-12v2 for measuring health-related quality of life of men and women living with HIV/AIDS Allyson Ion 1* , Wenjie Cai 1 , Dawn Elston 2 , Eleanor Pullenayegum 3 ,. that the SF-12v2 is an appropriate measure of health-related quality of life of men and women living with HIV/AIDS compared to the MOS-HIV demonstrating high correlation and good convergent and

Ngày đăng: 10/08/2014, 05:21

Từ khóa liên quan

Mục lục

  • Abstract

    • Background

    • Results

    • Conclusions

    • Background

    • Methods

    • Results

    • Discussion

    • Conclusions

    • Acknowledgements

    • Author details

    • Authors' contributions

    • Competing interests

    • References

Tài liệu cùng người dùng

Tài liệu liên quan